NCT05164198尚未招募4 期
Multicenter, Prospective Clinical Trial for Optimizing TNF Inhibitor Dose Adjustment in Ankylosing Spondylitis Patients With Stable Disease Activity
Hanyang University Seoul Hospital0 个研究点目标入组 448 人开始时间: 2022年1月15日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 448
- 主要终点
- Percentage of Participants who did not experience a flare
研究概览
简要总结
Participants maintaining stable disease activity of Ankylosing Spondylitis (AS) with standard-dose tumor necrosis factor inhibitor (TNFi) treatment will randomly split into two groups: maintaining standard-dose TNFi, versus reduced-dose TNFi. The proportion of participants not underwent flare between the two groups will be analyzed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documented diagnosis of Ankylosing spondylitis (AS) and meet the modified New York classification criteria for AS.
- •Subjects maintaining stable disease (Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] < 4) with standard-dose subcutaneous tumor-necrosis factor inhibitor (TNFi) treatment during previous 6 months from screening.
- •Ankylosing Spondylitis Disease Activity Score (ASDAS) < 2.1 at screening and 12 weeks prior to screening
- •In subjects treated with methotrexate or sulfasalazine, the dose should be maintained (methotrexate≤ 25mg/day, sulfasalazine ≤ 3 g/day) during previous 4 weeks before screening.
- •In subjects treated with systemic glucocorticoids, the dose should be less than 10mg/day of predinisolone or equivalent during at least 2 weeks from the screening
- •Subjects with stable dose of concomitant NSAID (including Cox2 inhibitors) during the 2 weeks from the randomization
排除标准
- •Exposure to more than 1 TNFi
- •History of hypersensitivity reaction to any TNFis
- •Subjects with concomitant fibromyalgia, as determined by the investigator
- •Subjects who have received any TNFis with reduced dosage
- •Presence of total spinal ankylosis ('Bamboo spine')
- •Female subjects who are breastfeeding, pregnant, or plan to become pregnant during the study
- •Subjects with a history of malignancies and lymphoproliferative disorder including lymphoma within 5 years (Basal cell carcinoma treated within previous 3 months and showing no evidence of recurrence, actinic keratosis, and treated cervical/colon carcinoma in situ were allowed.)
- •Subjects with current or history of severe, progressive, and/or uncontrolled renal, hepatic, hematological, endocrine, pulmonary, cardiac or neurological disease, as determined by the investigator
- •Subjects with significant laboratory abnormalities included but not limited to:
- •AST/ALT > 3.0 X ULN
- •White blood cell (WBC) < 3000/μL and/or absolute neutrophil count (ANC) < 1500/μL
- •Platelet count <100,000/μL and/or hemoglobin level <8.5 g/dL
- •Serum creatinine ≥ 1.5 X ULN
- •Subjected with any high-potency opioids (ex. methadone, hydromorphone, morphine, oxycodone, oxymorphone, fentanyl, levorphanol, buprenorphine, meperidine)
- •Subjects with current acute or chronic viral hepatitis B or C or with human immunodeficiency virus (HIV) infection
- •Subjects planning to receive any live attenuated vaccinations after screening
- •Subjects has history of chronic alcohol abuse or drug abuse within 6 months from screening
- •Subjects concomitantly treated with systemic glucocorticoid (>10mg/day of prednisolone or equivalent doses)
- •Subjects with any other condition that, in the Investigator's judgment, would make the subject unsuitable for inclusion in the study
结局指标
主要结局
Percentage of Participants who did not experience a flare
时间窗: From week 0 to week 48
Flare is defined as below: * A participant was considered to have experienced a flare if the participant had an Ankylosing spondylitis disease activity score (ASDAS) greater or equal to (≥ 2.1) at 2 consecutive visits or an ASDAS greater than (\> 3.5) at any visit. * If a participant had an ASDAS ≥ 2.1 and ≤ 3.5, the participant has an additional visit 4 weeks later and ASDAS is assessed by the investigator to confirm the flare. The ASDAS was calculated as the sum of the following components: 0.121 x Back pain (BASDAI Q2 result) 0.058 x Duration of morning stiffness (BASDAI Q6 result) 0.110 x PGADA (Patient's Global Assessment of Disease Activity) 0.073 x Peripheral pain/swelling (BASDAI Q3 result) 0.579 × (natural logarithm \[ln\] of the (CRP \[mg/L\] + 1)) Back pain, PGADA, duration of morning stiffness, peripheral pain/swelling and fatigue were all assessed on a numerical scale (0 to 10 units). Higher scores mean a worse outcome in the all following components.
次要结局
- Change from baseline in serum C-Reactive Protein (CRP) level at week 36.(Week 36)
- Change from baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) at week 48.(Week 48)
- Percentage of participants with Axial SpondyloArthritis International Society Partial Remission Response Criteria (ASAS-PR) Response at week 24.(Week 24)
- Change from baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at week 36.(Week 36)
- Change from baseline in Erythrocyte sedimentation rate (ESR) at week 12.(Week 12)
- Percentage of participants with Axial SpondyloArthritis International Society 20 % Response Criteria (ASAS20) Response at week 36.(Week 36)
- Percentage of participants with Axial SpondyloArthritis International Society 5/6 Response Criteria (ASAS5/6) Response at week 36.(Week 36)
- Percentage of participants with Axial SpondyloArthritis International Society Partial Remission Response Criteria (ASAS-PR) Response at week 12.(Week 12)
- Change from baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at week 24.(Week 24)
- Change from baseline in Erythrocyte sedimentation rate (ESR) at week 24.(Week 24)
- Change from baseline in Assessment of SpondyloArthritis international Society (ASAS)-health index (ASAS-HI) at week 24.(Week 24)
- The amount of NSAID intake between week 0 and 12(From week 0 to week 12)
- Change from baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at week 12.(Week 12)
- Change from baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at week 24.(Week 24)
- Change from baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at week 36.(Week 36)
- Percentage of participants with Axial SpondyloArthritis International Society 40 % Response Criteria (ASAS40) Response at week 36.(Week 36)
- Percentage of participants with Axial SpondyloArthritis International Society Partial Remission Response Criteria (ASAS-PR) Response at week 48.(Week 48)
- Change from baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at week 48.(Week 48)
- Change from baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) at week 12.(Week 12)
- Change from baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) at week 24.(Week 24)
- Change from baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) at week 36.(Week 36)
- Change from baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at week 48.(Week 48)
- Percentage of participants with Axial SpondyloArthritis International Society 20 % Response Criteria (ASAS20) Response at week 24.(Week 24)
- Percentage of participants with Axial SpondyloArthritis International Society Partial Remission Response Criteria (ASAS-PR) Response at week 36.(Week 36)
- Percentage of participants with Axial SpondyloArthritis International Society 20 % Response Criteria (ASAS20) Response at week 12.(Week 12)
- Percentage of participants with Axial SpondyloArthritis International Society 20 % Response Criteria (ASAS20) Response at week 48.(Week 48)
- Percentage of participants with Axial SpondyloArthritis International Society 40 % Response Criteria (ASAS40) Response at week 24.(Week 24)
- Percentage of participants with Axial SpondyloArthritis International Society 40 % Response Criteria (ASAS40) Response at week 48.(Week 48)
- Percentage of participants with Axial SpondyloArthritis International Society 40 % Response Criteria (ASAS40) Response at week 12.(Week 12)
- Percentage of participants with Axial SpondyloArthritis International Society 5/6 Response Criteria (ASAS5/6) Response at week 12.(Week 12)
- Percentage of participants with Axial SpondyloArthritis International Society 5/6 Response Criteria (ASAS5/6) Response at week 24.(Week 24)
- Percentage of participants with Axial SpondyloArthritis International Society 5/6 Response Criteria (ASAS5/6) Response at week 48.(Week 48)
- Change from baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at week 12.(Week 12)
- Change from baseline in Masstricht Ankylosing Spondylitis Enthesitis Score (MASES) at week 24.(Week 24)
- Change from baseline in swollen/tender joint count (0-44) at week 48.(Week 48)
- Change from baseline in Erythrocyte sedimentation rate (ESR) at week 48.(Week 48)
- Change from baseline in serum C-Reactive Protein (CRP) level at week 12.(Week 12)
- Change from baseline in Assessment of SpondyloArthritis international Society (ASAS)-health index (ASAS-HI) at week 48.(Week 48)
- Percentage of patients at Least One Adverse Event (AE) During the study period.(From week 0 and week 48)
- Change from baseline in Bath Ankylosing Spondylitis Disease Metrology Index (BASMI) at week 24.(Week 24)
- Change from baseline in Bath Ankylosing Spondylitis Disease Metrology Index (BASMI) at week 48.(Week 48)
- Change from baseline in Erythrocyte sedimentation rate (ESR) at week 36.(Week 36)
- Change from baseline in serum C-Reactive Protein (CRP) level at week 48.(Week 48)
- Change from baseline in 5-level EQ-5D version (EQ-5D-5L) at week 24.(Week 24)
- Change from baseline in 5-level EQ-5D version (EQ-5D-5L) at week 48.(Week 48)
- The amount of NSAID intake between week 12 and 24(From week 12 to week 24)
- Change from baseline in Masstricht Ankylosing Spondylitis Enthesitis Score (MASES) at week 48.(Week 48)
- Change from baseline in swollen/tender joint count (0-44) at week 24.(Week 24)
- Change from baseline in serum C-Reactive Protein (CRP) level at week 24.(Week 24)
- The amount of NSAID intake between week 24 and 36(From week 24 to week 36)
- The amount of NSAID intake between week 36 and 48(From week 36 to week 48)
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